Biomarkers for urologic chronic pelvic pain syndrome

Abstract

Described herein are methods for determining the status of Urologic Chronic Pelvic Pain Syndrome (UCPPS) in a subject and/or treating urologic chronic pelvic pain syndrome (UCPPS).

1 . A method for determining status of Urologic Chronic Pelvic Pain Syndrome (UCPPS) in a subject, comprising:
 obtaining a sample from the subject,
 wherein the subject has Urologic Chronic Pelvic Pain Syndrome (UCPPS), and 
 wherein the sample is selected from blood, serum, plasma, urine, and a combination thereof; 
   detecting an amount of at least one biomarker in the sample, wherein the biomarker is a protein selected from A1AT, APOC2, APOA4, ITIH2, VTNC, APOC1, CO4A, GEL, IC1, AACT, APOA1, A1BG, APOE, C1R, IGHG3, A1AG1, ALBU, VTDB, KLKB1, and a combination thereof; and   comparing the amount of the at least one biomarker in the sample from the subject to an amount of the at least one biomarker in a reference to determine the status of Urologic Chronic Pelvic Pain Syndrome (UCPPS) in a subject.   
     
     
         2 . The method of  claim 1 , wherein the reference is selected from:
 (i) a baseline value for the amount of the biomarker, wherein the baseline value is from at least one sample obtained from the subject at an earlier point in time;   (ii) a reference sample from a control subject, wherein the control subject does not have Urologic Chronic Pelvic Pain Syndrome (UCPPS);   (iii) a reference sample from a control subject, wherein the control subject has Urologic Chronic Pelvic Pain Syndrome (UCPPS);   (iv) a range of reference values for the amount of the biomarker, wherein the range of reference values is from at least one reference sample obtained from at least one healthy subject;   (v) a range of reference values for the amount of the biomarker, wherein the range of reference values is from at least one sample obtained from the subject at an earlier point in time; and   (vi) a range of reference values for the amount of the biomarker, wherein the range of reference values is from at least one reference sample obtained from at least one reference subject, wherein the reference subject has Urologic Chronic Pelvic Pain Syndrome (UCPPS).   
     
     
         3 . The method of  claim 2 , wherein an increase in the amount of the at least one biomarker in the sample from the subject relative to the amount of the at least one biomarker in the reference is used to determine a Rand Interstitial Cystitis Epidemiology (RICE) subtype in the subject,
 wherein the biomarker is selected from A1AT, ITIH2, VTNC, APOC1, IC1, AACT, APOA1, A1BG, APOE, C1R, IGHG3, A1AG1, ALBU, VTDB, and KLKB1.   
     
     
         4 . (canceled) 
     
     
         5 . The method of  claim 2 , wherein the biomarker is selected from A1AT, APOC2, APOA4, ITIH2, and VTNC, and
 wherein severity of urinary symptoms of Urologic Chronic Pelvic Pain Syndrome (UCPPS) in the subject is scored according to the urinary severity index.   
     
     
         6 . The method of  claim 5 , wherein the baseline value for the amount of the biomarker in the sample from the subject is dependent on a characteristic of the subject,
 wherein the biomarker is selected from A1AT, ITIH2, and VTNC, and   wherein the characteristic of the subject is selected from age, Rand Interstitial Cystitis Epidemiology (RICE) subtype, urinary severity index score, and a combination thereof.   
     
     
         7 . (canceled) 
     
     
         8 . The method of  claim 3 , wherein the baseline value for the amount of the biomarker in the sample from the subject is dependent on a characteristic of the subject,
 wherein the biomarker is selected from A1AT, ITIH2, VTNC, AACT, A1BG, IGHG3, A1AG1, ALBU, and VTDB, and   wherein the characteristic of the subject is selected from age, sex, and a combination thereof.   
     
     
         9 . (canceled) 
     
     
         10 . The method of  claim 2 , further comprising using the amount of the biomarker in the sample from the subject to distinguish between (a) a diagnosis of pelvic pain in the subject, and (b) a diagnosis of pelvic pain and beyond in the subject,
 wherein the biomarker is selected from APOC1 and CO4A.   
     
     
         11 . The method of  claim 10 , wherein the biomarker is APOC1, and
 wherein the amount of the biomarker in the sample from the subject is dependent on a characteristic of the subject,   wherein the characteristic of the subject is selected from sex, Rand Interstitial Cystitis Epidemiology (RICE) subtype, and a combination thereof.   
     
     
         12 . (canceled) 
     
     
         13 . The method of  claim 2 , further comprising using the amount of the biomarker in the sample from the subject to assist in diagnosing flare status of Urologic Chronic Pelvic Pain Syndrome (UCPPS) in the subject,
 wherein the biomarker is GELS.   
     
     
         14 . The method of  claim 2 , wherein the amount of the biomarker in the sample from the subject is increased relative to the amount of the biomarker in the reference,
 wherein the biomarker is selected from C1R and A1AT, and   wherein the reference is a reference sample from a control subject, wherein the control subject does not have Urologic Chronic Pelvic Pain Syndrome (UCPPS).   
     
     
         15 . The method of  claim 2 , wherein the biomarker is A1AT, and
 wherein the amount of the biomarker in the sample from the subject is dependent on a characteristic of the subject,   wherein the characteristic of the subject is selected from age, sex, urinary severity index score, and a combination thereof.   
     
     
         16 . The method of  claim 2 , wherein the biomarker is C1R, and
 wherein the amount of the biomarker in the sample from the subject is dependent on a characteristic of the subject,   wherein the characteristic of the subject is selected from age, sex, and a combination thereof.   
     
     
         17 . The method of  claim 2 , wherein the biomarker is selected from APOA1, A1BG, APOE, A1AT, IGHG3, ALBU, VTDB, VTNC, and ITIH2, and
 wherein the amount of the biomarker in the sample from the subject relative to the amount of the biomarker in the reference determines the subject's Rand Interstitial Cystitis Epidemiology (RICE) subtype.   
     
     
         18 . (canceled) 
     
     
         19 . The method of  claim 2 , wherein the biomarker is selected from AACT, A1BG, C1R, A1AT, IGHG3, VTDB, VTNC, IC1, and
 wherein the amount of the biomarker in the sample from the subject relative to the amount of the biomarker in the reference determines the subject's Rand Interstitial Cystitis Epidemiology (RICE) subtype.   
     
     
         20 . (canceled) 
     
     
         21 . The method of  claim 2 , wherein the biomarker is A1AT, and
 wherein the amount of the biomarker in the sample from the subject relative to the amount of the biomarker in the reference determines the subject's Rand Interstitial Cystitis Epidemiology (RICE) subtype.   
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 2 , wherein the biomarker is selected from A1AT, A1AG1, and VTNC, and
 wherein the amount of the biomarker in the sample from the subject relative to the amount of the biomarker in the reference determines the subject's Rand Interstitial Cystitis Epidemiology (RICE) subtype.   
     
     
         24 . (canceled) 
     
     
         25 . The method of  claim 2 , wherein the amount of the biomarker in the sample from the subject is dependent on a characteristic of the subject,
 wherein the characteristic of the subject is sex, and   wherein the biomarker is selected from IC1, AACT, APOC1, and KLKB1.   
     
     
         26 . The method of  claim 2 , wherein the amount of the biomarker in the sample from the subject is dependent on a characteristic of the subject,
 wherein the characteristic of the subject is age, and   wherein the biomarker is selected from A1AG1 and ALBU.   
     
     
         27 . The method of  claim 2 , wherein the amount of the biomarker in the sample from the subject is dependent on a characteristic of the subject,
 wherein the characteristic of the subject is selected from sex, age, and a combination thereof, and   wherein the biomarker is selected from A1BG, IGHG3, and VTDB.   
     
     
         28 . The method of  claim 2 , wherein the amount of the biomarker in the sample from the subject is dependent on a characteristic of the subject,
 wherein the characteristic of the subject is selected from age, urinary severity index score, and a combination thereof, and   wherein the biomarker is ITIH2.   
     
     
         29 . The method of  claim 2 , wherein the amount of the biomarker in the sample from the subject is dependent on a characteristic of the subject,
 wherein the characteristic of the subject is selected from age, sex, urinary severity index score, and a combination thereof, and   wherein the biomarker is selected from A1AT and VTNC.   
     
     
         30 . The method of  claim 1 , further comprising administering a treatment for Urologic Chronic Pelvic Pain Syndrome (UCPPS) to the subject. 
     
     
         31 . The method of  claim 1 , further comprising administering a treatment for a symptom of Urologic Chronic Pelvic Pain Syndrome (UCPPS) to the subject. 
     
     
         32 . The method of  claim 1 , wherein the amount of the biomarker is detected by mass spectrometry, an immunoassay, or a capture and detection assay. 
     
     
         33 . The method of  claim 32 , wherein
 the mass spectrometry comprises operating a mass spectrometer,   the immunoassay comprises performing the immunoassay, and   the capture and detection assay comprises performing the capture and detection assay.   
     
     
         34 . (canceled) 
     
     
         35 . (canceled) 
     
     
         36 . The method of  claim 1 , wherein the biomarker is an isoform, single-nucleotide polymorphism, or fragment of the protein. 
     
     
         37 . The method of  claim 1 , wherein the protein comprises a post-translational modification. 
     
     
         38 . The method of  claim 1 , wherein the subject is human.